Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health) (RASMUS)

May 3, 2026 updated by: Novo Nordisk A/S

Effect of CagriSema, Semaglutide and Cagrilintide on Skeletal Muscle Insulin Sensitivity, Composition and Function

The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight. Participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to treat people with type 2 diabetes and excess body weight) or placebo (a placebo looks like the treatment being tested but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants will be in this clinical study up to 15 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Male or female.
  • Age 50-70 years (both inclusive) at the time of signing the informed consent.
  • Body Mass index (BMI) between 30.0 kilograms per square meter (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening (V1).
  • Excess body weight should be due to excess adipose tissue, as judged by the investigator.
  • Participant has a wish to lose at least 25 percentage (%) of body weight within 52 weeks of treatment.

Exclusion criteria

  • Any leg amputations.
  • Female participants who are not postmenopausal at screening.
  • Any clinically significant body weight change (greater than or equal to [>=] 5% self-reported change) or dieting attempts within 90 days before screening.
  • Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist or a medication with GLP-1 activity within 90 days before screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CagriSema
Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) for up to 52 weeks.
Drug: Semaglutide
Participants will receive semaglutide subcutaneously.
Drug: Cagrilintide
Participants will receive cagrilintide subcutaneously.
Experimental: Semaglutide
Participants will receive once weekly s.c. dose of semaglutide for up to 52 weeks.
Drug: Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Drug: Semaglutide
Participants will receive semaglutide subcutaneously.
Experimental: Cagrilintide
Participants will receive once weekly s.c. dose of cagrilintide for up to 52 weeks.
Drug: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
Drug: Cagrilintide
Participants will receive cagrilintide subcutaneously.
Placebo Comparator: Placebo
Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide for up to 52 weeks.
Drug: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
Drug: Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle
Time Frame: Baseline to Week 51
Measured in micromoles per 100 grams per minute (μmol/100g/min).
Baseline to Week 51

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insulin-stimulated FDG uptake in skeletal muscle
Time Frame: Baseline to Week 20
Measured in μmol/100g/min.
Baseline to Week 20
Change in insulin-stimulated FDG uptake in skeletal muscle
Time Frame: Baseline to Week 51
Measured in μmol/100g/min.
Baseline to Week 51

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2026

Primary Completion (Estimated)

April 28, 2028

Study Completion (Estimated)

June 9, 2028

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9838-8411
  • U1111-1321-8655 (Other Identifier: World Health Organization (WHO))
  • 2025-522920-28 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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